Efficacy, Safety, and Tolerability Study of Lunsekimig Compared With Placebo in Adult Participants With Inadequately Controlled Chronic Obstructive Pulmonary Disease (COPD), Characterized by an Eosinophilic Phenotype
A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study, to Investigate the Efficacy and Safety of Lunsekimig in Adult Participants With Inadequately Controlled Chronic Obstructive Pulmonary Disease (COPD) Characterized by an Eosinophilic Phenotype
Sanofi
942 participants
Sep 17, 2025
INTERVENTIONAL
Conditions
Summary
This is a parallel, Phase 2/Phase 3, 3-arm study to investigate the efficacy, safety, and tolerability of subcutaneous (SC) treatment with lunsekimig compared with placebo in adult participants (aged 40 to 80 years, inclusive) with inadequately controlled Chronic obstructive pulmonary disease (COPD) characterized by an eosinophilic phenotype. Participation to the study consists of 3 periods: * Screening period of up to 4 weeks * Randomized intervention period of approximately 48 weeks * Follow-up period: Approximately 8 weeks The study duration will be up to 60 weeks.
Eligibility
Inclusion Criteria9
- Between 40 to 80 years of age
- Physician diagnosed chronic obstructive pulmonary disease (COPD) ≥1 year
- Post-bronchodilator forced expiratory volume in 1 second (post-BD FEV1) ≥ 20% and ≤ 70% of predicted value and FEV1/FVC (forced expiratory volume in 1 second /forced vital capacity) \<0.70
- Former or current smokers ≥10 pack-years
- Chronic Airways Assessment Test (CAAT) ≥10
- ≥2 moderate or ≥1 severe COPD exacerbations in the prior year
- Triple (ICS+LABA+LAMA) COPD therapy ≥12 consecutive weeks
- EOS (blood eosinophil count) ≥ 150 cells/μL
- ≤ Body Mass Index ≤ 40.0 kg/m2
Exclusion Criteria11
- Participants are excluded from the study if any of the following criteria apply:
- Asthma, including pediatric asthma, or ACOS
- Significant pulmonary disease other than COPD
- Long-term oxygen therapy \>4.0 L/min or requirement of \>2.0 L/minO2 saturation to maintain oxygen saturation \>88%
- Unstable disorder that can impact participants safety or study outcomes
- Active or incompletely treated tuberculosis
- Current or past malignancies
- Concomitant therapies:
- long-term macrolides or iPDE-4 unless on stable therapy for \> 6 months
- any biologic therapy or systemic immunosuppressant within 8 weeks or 5 half-lives prior to Screening
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Interventions
Pharmaceutical form: solution for injection in prefilled syringe - Route of administration: Subcutaneous injection
Pharmaceutical form:s olution for injection - Route of administration: Subcutaneous injection
Locations(150)
View Full Details on ClinicalTrials.gov
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NCT07190222